Date: 20070223
Docket: A-76-06
Citation: 2007 FCA 83
CORAM: NOËL
J.A.
NADON
J.A.
MALONE
J.A.
BETWEEN:
RATIOPHARM, A DIVISION OF
RATIOPHARM INC.
Appellant
and
THE MINISTER OF HEALTH, ABBOTT
LABORATORIES and ABBOTT LABORATORIES LIMITED
Respondents
REASONS FOR JUDGMENT
NOËL J.A.
[1]
This is an
appeal from the judgment of Campbell J. of the Federal Court (2006 FC 69)
granting Abbott Laboratories and Abbott Laboratories Limited’s (collectively,
“Abbott” or “the respondents”) application under the Patented Medicines
(Notice of Compliance) Regulations, SOR/93-133 (“PMNOC Regulations”) for an
order prohibiting the Minister of Health (“the Minister”) from issuing a Notice
of Compliance (“NOC”) to Ratiopharm (or “the appellant”) until after the
expiration of Canadian Patent No. 2,393,614 (“the ‘614 Patent”).
[2]
The
prohibition order was issued with respect to clarithromycin, the active
medicinal ingredient in Abbott’s Biaxin tablets. The appellant seeks to have
this order set aside alleging, inter alia, that Campbell J. misconstrued
the ‘614 Patent, and that in any event he erred in failing to hold that this patent
was invalid on the ground of obviousness.
RELEVANT FACTS
[3]
The ‘614
Patent is a formulation patent entitled “Antibacterial Clarithromycin
Compositions and Processes for Making Same”. The alleged invention disclosed
in the ‘614 Patent is the abridgement of the clarithromycin composition by
removing components (i.e., excipients) from the non-abridged composition.
[4]
An
excipient is an inert, non-medicinal ingredient that is added to a
pharmaceutical formulation to give the formulation desired properties.
Excipients include diluents, binders, lubricants, disintegrants, glidants, and
colouring agents.
[5]
The
commercially-available, non-abridged clarithromycin composition is marketed by
Abbott under the name Biaxin. This non-abridged formulation is described in
the ‘614 Patent as follows:
The currently
commercially-available, non-abridged clarithromycin composition consists
essentially of the following components: clarithromycin, colloidal silicon
dioxide, D&C yellow dye No. 10, extra-granular sodium croscarmellose,
extra-granular microcrystalline cellulose (Avicel® PH-102), intra-granular
sodium croscarmellose, intra-granular microcrystalline cellulose (Avicel®
PH-101), magnesium stearate powder, povidone, pre-gelatinized starch, 200 proof
alcohol, stearic acid, talc, and water.
[6]
Claim 1 of
the ‘614 Patent (also referred to as the “abridged composition”) is the only
claim in issue. It reads:
An abridged
antibacterial composition consisting essentially of clarithromycin, water, an
intra-granular excipient, and an extra-granular excipient, in which the
intra-granular excipient consists essentially of povidone, sodium
croscarmellose, and microcrystalline cellulose, and the extra-granular
excipient consists essentially of sodium croscarmellose, microcrystalline
cellulose, colloidal silicon dioxide, and impalpable magnesium stearate powder.
[7]
In
construing Claim 1, Campbell J. placed particular emphasis on the dependent
claim set out in Claim 3 which reads:
The composition of Claim
1 which is essentially ethanol-free.
[8]
Ratiopharm
is seeking a NOC for 250 mg and 500 mg clarithromycin tablet formulations for
oral administration. In its abbreviated new drug submission, Ratiopharm has
made reference to Abbott’s Biaxin tablets in respect of which the ‘614 Patent
has been listed on the patent register maintained under the PMNOC Regulations.
[9]
On January
9, 2004, Ratiopharm filed a Notice of Allegation (“NOA”) pursuant to section 5
of the PMNOC Regulations in respect of the ‘614 Patent. In its NOA, Ratiopharm
alleged:
Claim 1 requires an
intra-granular excipient consisting essentially of povidone, sodium
croscarmellose and microcrystalline cellulose. The term “consisting” is used
to specify the constituent elements in the claimed combination to the exclusion
of all other elements, and in particular to the exclusion of all elements that
are present in the so called “non-abridged” composition described at page 2,
lines 17 to 22 of the ‘614 Patent that are not included in the claimed
combination. The intra-granular excipient of the ratiopharm clarithromycin
product also contains pre-gelatinized starch which is not among the claimed
ingredients and accordingly does not consist essentially of the claimed
ingredients.
[10]
In
response to the NOA, Abbott filed an application pursuant to subsection 6(2) of
the PMNOC Regulations for an order to prohibit the Minister from issuing an NOC
to Ratiopharm in respect of its tablet formulations until the expiry of the
‘614 Patent.
[11]
Ratiopharm
later advanced the further position that Claim 1 could be construed in an
alternate fashion. Specifically, Ratiopharm submitted that the phrase
“consisting essentially of” could be interpreted to include the specified
ingredients as well as other ingredients that do not materially affect the
characteristics of the product.
[12]
Finally, before
Campbell J., Ratiopharm alleged that regardless of the construction given to
Claim 1, Abbott’s abridged composition was invalid based on obviousness, and
that accordingly no infringement could result from its proposed tablet
formulations.
FEDERAL COURT DECISION
[13]
At the
beginning of his reasons, Campbell J. enumerated three substantive issues for
determination: construction, infringement, and validity. On the first issue,
Campbell J. held that the patent claims are to be given a purposive
construction, and should be read from the perspective of a person skilled in
the art to whom the patent is addressed (Reasons, paras. 39 and 40).
[14]
Applying
this approach, he accepted Abbott’s contention that the term “consisting
essentially of” in Claim 1 could not be read to mean “consisting only of”
(Reasons, paras. 50 to 79). He said at para. 56:
Given the definition of
“abridged composition”, I find that clear meaning can be given to the words of
Claim 1 as argued by Abbott. That is, taking into consideration all of the
ingredients of the non-abridged composition, the abridged composition must
include all of the ingredients listed in Claim 1, and, with respect to those
that remain to choose from, at least one is not to be included. There are
thirteen ingredients in the non-abridged composition when colour is excluded.
Thus, after including all nine ingredients listed in Claim 1, those that remain
from the non-abridged composition to choose from are: (1) pre-gelatinized
starch; (2) 200 proof alcohol (ethanol); (3) stearic acid; and (4) talc.
[15]
Campbell
J. went on to find that Ratiopharm’s product infringes the ‘614 Patent given
Ratiopharm’s concession that its formulation comes within Claim 1 in the event
that Abbott’s construction was found to be correct (Reasons, para. 83).
[16]
Campbell J. later explained that he
would not deal with Ratiopharm’s alternative construction on the ground that it
had not been alleged in the NOA (Reasons, para. 80).
[17]
With
respect to the alleged invalidity on the basis of obviousness, Campbell J. found
the ‘614 Patent to be inventive and brought an improvement over the prior art
(Reasons, paras. 84 to 94).
[18]
He went on
to issue the order of prohibition sought by the respondents as outlined in paragraph
1 above.
[19]
This is
the decision under appeal.
ISSUES
[20]
The
issues, as defined by the Appellant, are as follows:
a. Did the
Applications Judge err in construing Claim 1 of the ‘614 Patent as meaning that
the abridged composition must include all the ingredients listed in Claim 1,
since at least one ingredient from the non-abridged composition is not
included?
b. Did the
Applications Judge err in misapplying the test for obviousness, specifically:
i. That there
required evidence that persons skilled in the art would know from the prior art
which location to put what excipients in an abridged formulation at attain
bioequivalence to the non-abridged formulation of Biaxin?
ii. In requiring
that the skilled formulator necessarily arrive at the ‘614 Patent?
iii. In requiring
that the test for obviousness exclude routine testing?
iv. In concluding
that the testing required to arrive at the invention in the ‘614 Patent was not
routine, but “intensively investigative”?
c. Did the
Applications Judge err in holding that Ratiopharm had the burden to prove, on a
balance of probabilities, that the ‘614 Patent was invalid?
ANALYSIS
[21]
In support
of its allegation that Campbell J. misconstrued Claim 1, Ratiopharm contends
that he made three identifiable errors. First, Ratiopharm alleges that
Campbell J. erred in law in refusing to consider its alternative construction.
Second, Ratiopharm contends that Campbell J. made a palpable and overriding
error in his assessment of the significance of the colour in the non-abridged
composition. Lastly, Ratiopharm argues that Campbell J. failed to perform his
judicial function by placing unwarranted reliance on the opinions given by
Abbott’s experts. According to Ratiopharm, these errors are such that this
Court must conduct a de novo analysis of Claim 1.
[22]
Dealing
with the first alleged error, the allegation made by Ratiopharm in its NOA is that
the composition in Claim 1 is limited solely to the ingredients recited in the
claim. The alternative contention advanced later is that the phrase
“consisting essentially of” is broad enough to include other ingredients that
did not materially affect the characteristics of the purported invention.
[23]
Ratiopharm
argued before Campbell J. that although the alternative construction was not in
its NOA, Abbott had sufficient notice of it and indeed led no evidence to the
effect that they were misled. However, the record reveals that Ratiopharm first
advanced this alternative construction in its responding expert evidence that
is after Abbott had filed its expert evidence. Abbott’s expert (Dr. Amidon)
states in his reply affidavit that the alternative construction is new and not
in the NOA.
[24]
In my view,
Campbell J. correctly discounted the alternative construction put forth by
Ratiopharm since it complied neither with its NOA, nor with section 5 of the
PMNOC Regulations. In particular, it seems to me that the facts underlying the
alternative construction go beyond those laid out in the NOA. It assumes that
contrary to what was initially alleged, Claim 1 covers more than the
constituent elements which are specifically mentioned. In AB Hassle v.
Apotex Inc., 2002 FCT 931 at paragraph 63, the Federal Court stated:
[63] The NOA
must provide all of the facts the generic producer intends to rely upon in
subsequent prohibition proceedings and it cannot rely on facts that exceed
those laid out in the NOA. The NOA must address all of the patent claims that
describe the basic invention or else its NOA will be defective and not in
compliance with section 5 of the Regulations. See Genpharm Inc.
v. The Minister of Health and Procter and Gamble Pharmaceuticals Canada Inc.
2002 F.C.A. 290 (F.C.A.), per Rothstein J.A. at paragraphs 22 to 25:
[22] However, the notices of
allegation and the detailed statement of legal and factual basis for the
allegation must provide all the facts the generic producer intends to rely upon
in subsequent prohibition proceedings. It cannot rely on facts that exceed
those laid out in its detailed statement. See Merck Frosst Canada Inc. v. Canada
(Minister of Health), (2002), 12 C.P.R. (4th) 447 at paragraph 19 per Stone
J.A.
[23] The requirement of
subparagraph 5(1)(b)(iv) that the generic producer “... allege ... that no
claim for the medicine itself and no claim for the use of the medicine would be
infringed ...” necessarily implies that the detailed statement must provide the
legal and factual basis for the allegation that none of the patent claims will
be infringed.
[24] I do not say that it is
necessary for the generic producer to address each and every dependent patent
claim if the basic claim or claims that describe the invention are addressed in
the detailed statement. However, it is not open to the generic producer to
ignore patent claims that describe the basic invention. If it does so,
it will not be providing facts demonstrating that "no claim for the use of
the medicine would be infringed", and its notice of allegation will be
defective and not in compliance with section 5.
[…]
[25]
More
recently, this Court in AB Hassle v. Apotex Inc., [2006] F.C.J. No. 203;
2006 FCA 51, reiterated (at para. 4) that the NOA (together with the detailed
statement) is the document that frames the debate in a subsequent prohibition proceeding,
and that a second person cannot, in response to a first person’s application
for a prohibition, present evidence and argument relating to an issue that is
outside the scope of the NOA.
[26]
Using
another approach, the appellant argues that the court is entitled to adopt a
construction of a claim that differs from the one put forth by the parties
(Appellant’s Memorandum, para. 34; Whirlpool Corp. v. Camco Inc., 2000
SCC 67 at para. 61), and that, to that extent, no construction can be said to
be irrelevant.
[27]
No doubt
this is so if the record is capable of supporting the new construction. But, Campbell
J. notes in this case that the alternative construction is based on conflicting
opinions given by Ratiopharm’s own experts on the proper interpretation of the
phrase “consisting essentially of” (Reasons, para. 78). He points to Dr.
Miller’s affidavit which states that the alternate construction is “one that a
Skilled Formulator would unlikely adopt” and is “contrary to the formulator’s
intuition” (Miller Affidavit, AB. Vol. X, Tab M, p. 2007-2008). Given this record,
it was reasonably open to Campbell J. not to give the
alternative construction further consideration (Reasons, para. 80).
[28]
The second
error relates to the colour of the non-abridged composition. Relying on the
evidence of one of the experts produced by Abbott (Dr. Byrn), Campbell J. found
that the colour in the non-abridged formulation is irrelevant in formulating an
abridged composition. Dr. Byrn admitted in cross-examination that the dye was
in the core of the non-abridged composition rather than an ingredient of a film
coating.
[29]
However, Dr.
Byrn was not asked whether this admission had an impact on his opinion as to
the construction of Claim 1. As a result, it was open to Campbell J. to infer
that it did not.
[30]
At the
hearing of the appeal, Counsel for Ratiopharm contended that Campbell J. made a
third error, of a palpable and overriding nature, when he construed specific
passages of
Dr. Amidon’s evidence during cross-examination as referring to ingredients
incidental to the abridged composition (Reasons, para. 64). This issue as to
what was said by Dr. Amidon during his cross-examination was the subject of
extensive debate before Campbell J. After considering this evidence, Campbell
J. rejected Ratiopharm’s contention that Dr. Amidon’s opinion pertained to
ingredients which were of consequence to the abridged composition. Recognizing
that the evidence was open to interpretation, it has not been shown that
Campbell J.’s finding does not find support in Dr. Amidon’s testimony.
[31]
Beyond
these three specific errors, the appellant contends that Campbell J. “abdicated
his judicial function” by adopting unsubstantiated conclusions proffered by
Abbott’s experts as to the proper construction of Claim 1. It is true that
Campbell J. adopted in whole the construction proposed by Abbott’s experts.
But it cannot be said that he thereby committed a reviewable error. Abbott’s
proposed interpretation of Claim 1 (i.e., that the term “consisting essentially
of” cannot be read to mean “consisting only of”) is consistent with Claim 3,
which provides that Claim 1 can be read to include ethanol even though it is
not in the listed ingredients in Claim 1. In contrast, the construction
proposed by Ratiopharm in its NOA is that the composition in Claim 1 is limited
to ingredients recited in the claim “to the exclusion of all other elements and
in particular to the exclusion of all elements that are present in the
so-called “non-abridged” composition” of which ethanol is one.
[32]
Ratiopharm
argued by reference to the decision of Jacob L.J. in Ultra-frame (U.K.) Ltd.
v. Eurocell Building Plastics Limited, [2005] EWCA (Civ) 761 at para. 41
(C.A.), that Claim 3 could not be read as allowing ethanol to be added pursuant
to Claim 1. Counsel argued that on a purposive analysis Claim 1 and Claim 3
should be read as duplicate claims.
[33]
There is
no doubt that claims can be repeated and that this will occur from time to time.
However, the starting assumption must be that claims are not redundant, and
only if a purposive analysis shows that claims are in effect duplicated can
this construction be adopted. In this case, Claim 1 is an independent claim
which, absent a contrary indication, must be read in a manner consistent with
Claim 3 which is dependent on it (see Halford et al v. Seed Hawk Inc. et al,
31 C.P.R. (4th) 434, per Pelletier J. (as he then was) at paras. 92
to 98) . This is how Campbell J. read Claim 1. I can see no error in
this regard.
[34]
Moreover,
Abbott’s construction of Claim 1 is consistent with the “preferred embodiment”
set out in the disclosure of the ‘614 Patent, namely the embodiment in which
200 proof alcohol, stearic acid, and talc have been omitted from the
non-abridged formulation, while pre-gelatinized starch is included (A.B., vol.
II, p. 84). As the respondents argue, this conforms with Abbott’s proposed
construction which allows for the presence of starch and but is inconsistent
with the constructions proposed by Ratiopharm, neither of which allow starch to
be added.
[35]
In my
respectful view, it has not been shown that Campbell J. erred when he held that
the person skilled in the art would read Claim 1 of the ‘614 Patent as meaning
that the abridged composition must include all the listed ingredients, with at
least one ingredient from the non-abridged composition being excluded.
[36]
Turning to
the issue of obviousness, the applicable test was set out in Beloit Canada
Ltd. v. Valmet OY (1986), 8 C.P.R. (3d) 289, at 294:
The test for obviousness
is not to ask what competent inventors did or would have done to solve the
problem. Inventors are by definition inventive. The classical touchstone for
obviousness is the technician skilled in the art but having no scintilla of
inventiveness or imagination; a paragon of deduction and dexterity, wholly
devoid of intuition; a triumph of the left hemisphere over the right. The
question to be asked is whether this mythical creature (the man in the Clapham
omnibus of patent law) would, in the light of the state of the art and of
common general knowledge as at the claimed date of invention, have come
directly and without difficulty to the solution taught by the patent. It is a
very difficult test to satisfy.
[37]
In this
case, the Applications Judge after quoting the above passage, accepted Abbott’s
submission (at paragraph 94 of his Reasons) to the effect that:
The ‘614 Patent is an
improvement patent and is inventive because it discloses, for the first time,
which specific excipients, in which locations, are required to make the
non-abridged composition and discloses which excipients can be removed and
retained, to make an abridged composition. As Dr. Amidon emphasized, an
abridged clarithromycin composition would be particularly challenging since
clarithromycin is a class IV compound, is practically insoluble, has low
permeability, an unpalatable taste, and is a large complex molecule with
numerous functional groups which would pose degradation issues. This is far
greater than the “scintilla of inventiveness” necessary to support the validity
of the patent.
[38]
Ratiopharm
takes issue with the contention that the ‘614 Patent involves the slightest
degree of inventiveness. It argues that Campbell J. reached the conclusion
that the patent was inventive on the erroneous assumption that the test for
obviousness excludes routine testing. Reference is made to paragraph 99 of the
reasons.
[39]
In my
view, Campbell J.’s comment, at paragraph 99, that “testing is not allowed
based on a consistent line of authority of this Court,” was articulated in the
context of the exercise of hindsight (see Procter & Gamble
Pharmaceuticals Canada Inc. v. Canada (2004), 32 C.P.R. (4th)
224 (F.C.T.D.) at 36, affirmed in 37 C.P.R. (4th) 289 (F.C.A.) at
paras. 43-47). Campbell J. did not hold that the test for obviousness does not
permit routine testing (i.e., confirming predictable qualities of known
compounds). The express finding that he made is that the type of testing
required in this case would not be “routine”, but “intensely investigative”
(Reasons, para. 101).
[40]
The
appellant further argues that Campbell J.’s finding that intense investigation
was required is based on the erroneous assumption that Claim 1 required the
abridged formulation to be bioequivalent to the non-abridged formulation. In
this respect, Counsel for the appellant refers to paragraph 90 of the reasons,
where Campbell J. appears to assume that bioequivalence is required.
[41]
However,
when regard is had to the reasons, Campbell J.’s finding that intense
investigation was required to arrive at the patented formulation is not tainted
by this apparent misapprehension. It is based on the assertions of Dr. Miller
(who had no such misapprehension) to the effect that extensive evaluation of
the non-abridged formulation had to be conducted (Reasons, paras. 96 and 97)
and that “the person skilled in the art would not known in advance of selecting
candidates for removal and doing experiments, how many, if any, excipients
could be removed, in what amount and in which combination” (Reasons, para. 98).
[42]
Counsel
for Ratiopharm argued for the first time during the hearing of the appeal that
Campbell J.’s assessment of Dr. Miller’s evidence was patently wrong. I have
reviewed Dr. Miller’s evidence and in particular the evidence that he gave on
cross-examination. In my view, Dr. Miller’s evidence allowed for the conclusion
reached by Campbell J.
[43]
Finally, Ratiopharm
submits that Campbell J. improperly placed the onus on Ratiopharm to prove, on
a balance of probabilities, that the ‘614 Patent was invalid (Pfizer Canada
Inc. v. Canada, 2006 FC 220, at paras. 10-11).
The short answer is that this case was not decided on the basis of onus. Both
sides filed extensive evidence and Campbell J. found in favour of Abbott on a
balance of probabilities (see Bayer v. Canada (Minister of National Health and
Welfare),
(2000), 6 C.P.R. (4th) 285 (F.C.A.) at para. 9).
[44]
I would
dismiss the appeal with costs.
“Marc Noël”
“I
agree
M.
Nadon J.A.”
“I
agree
B.
Malone J.A.”
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